Novo Nordisk applies to FDA for approval of higher dose Wegovy injection 7.2 mg
Recently, Novo Nordisk announced that it has submitted a new drug application (SNDA) to the US Food and Drug Administration (FDA) for a higher dose of semaglutide injection 7.2mg supplement. The application is intended to be used for long-term weight management in adult obese patients based on the CNPV Accelerated Program, on the basis of reducing calorie intake and increasing physical activity. After the FDA accepts the application, it is expected to be approved within 1-2 months.
This sNDA includes results from the STEP UP experiment. The STEP UP trial is a 72 week randomized, double-blind, placebo-controlled, and active control superiority trial evaluating the efficacy and safety of once weekly semaglutide 7.2mg as an adjuvant therapy for lifestyle intervention in 1407 adult obese patients (BMI 30kg/m2) compared to placebo and semaglutide 2.4mg. Patients with diabetes were not included in this study.
Compared to the 2.4mg group or placebo group treated with semaglutide, the 7.2mg group treated with semaglutide had more common gastrointestinal adverse events and sensory abnormalities. 6.8% of participants in the 7.2 mg group of semaglutide reported serious adverse events, compared to 10.9% in the 2.4 mg group and 5.5% in the placebo group. The European Medicines Agency (EMA), as well as regulatory bodies in other countries, are approving a new higher dose of Wegoyy @ (semaglutide 7.2mg). Novo Nordisk expects EU registration agencies to make approval decisions in the first quarter of 2026.
The first administration of SA1211 injection, a dual target siRNA molecule independently developed by Shian Biotechnology, has been completed
Recently, Suzhou Shian Biotechnology announced that its independently developed SA1211 injection phase I clinical trial (acceptance number: 2025LP02762) has successfully completed its first administration on November 25, 2025 at the First Hospital of Jilin University, marking the official entry of this innovative drug into the clinical development stage.
This clinical trial (CDE registration number: CTR20254317) aims to evaluate the safety, tolerance, pharmacokinetics (PK) and initial efficacy of SA1211 injection. The design scheme of randomization, double talk, placebo control, and dose escalation is used to conduct single and multiple administration observation in healthy subjects and patients with chronic hepatitis B, grouped according to the preset dose, and the dose range covers multiple gradients from low to high, so as to comprehensively evaluate the safety window and dose effect relationship of the drug. Time Safety Biology will promote the phase II patient population trial according to the data in this phase.
At present, the biggest challenge of hepatitis B treatment is the rebound of drug withdrawal after virus clearance. SA1211 injection is the world's first single molecule dual target siRNA drug to enter clinical trials. It can not only directly eliminate hepatitis B virus, but also open immune checkpoints to help patients recover their acquired immunity to hepatitis B virus, thus solving the problem of virus rebound after drug withdrawal. It is expected that through rigorous clinical trials, a new treatment scheme with both long-term effectiveness and safety will be provided for patients, bringing new dawn to the functional cure of chronic hepatitis B patients worldwide.
New weight loss medication! Hengrui SHR-2906 received clinical approval from NMPA
On November 28, 2025, the clinical trial application of Hengrui Pharmaceutical SHR-2906 Injection was approved by NMPA for the treatment of obesity.
Hengrui Pharmaceutical has made a deep layout in the field of weight loss and reached a $6 billion NewCo model overseas cooperation in May 2024. Kailera Therapeutics recently announced the completion of a $500 million Series B financing, accelerating the clinical development of corresponding pipelines. The GLP-1/GIP dual target agonist HRS-9531 was approved for market application in September this year, followed by oral versions of small molecule GLP-1 receptor agonists HRS-7535 and HRS-9531. In addition, the GLP-1/GIP/GCG triple target agonist HRS-4729 is currently in phase I clinical trials.
SHR-2906 Injection, a Class 1 biopharmaceutical new drug under Hengrui Pharmaceutical, was approved for clinical trials by the National Medical Products Administration on November 28, 2025. The proposed indication is overweight or obesity. As a weight loss drug with a new mechanism of action, its promotion will enrich Hengrui Pharmaceutical's pipeline layout in the field of weight loss. The company has currently built a weight loss research and development team covering multiple types and dosage forms of GLP-1/GIP dual targets, small molecule GLP-1 receptor agonists (including oral versions), GLP-1/GIP/GCG triple targets, etc. HRS-9531 has submitted a marketing application, and the clinical launch of SHR-2906 Injection will further strengthen its market competitiveness in this field and is also expected to contribute to overweight or obesity. The crowd brings new treatment options.
Tangram announces TGM-312CTA application submission, RNAi therapy opens clinical exploration for MASH
Recently, Tangram Therapeutics ("Tangram"), which is committed to combining artificial intelligence and RNAi drugs, announced that it has submitted a clinical trial application (CTA) to the UK drug regulatory agency MHRA to initiate the Phase 1/2 clinical trial of its core pipeline project TGM-312. TGM-312 is a GalOmic siRNA in the research and development stage, aimed at specifically silencing a novel gene in liver cells for the treatment of metabolic dysfunction associated steatohepatitis (MASH).
The Phase 1/2 study will evaluate TGM-312 in healthy adult volunteers and MASH patients to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the candidate drug. The study also included liver biopsy, exploratory imaging examination, and biomarker endpoint assessment of MASH patients. Subject to regulatory approval, the research is expected to commence in the UK in early 2026, with preliminary data expected to be released in the second half of 2026.
TGM-312 is a novel candidate drug for GaINAC conjugated interfering RNA (GalNAC siRNA) therapy, which is being developed for safe and effective treatment of metabolic dysfunction associated steatohepatitis (MASH). TGM-312 has the potential to achieve patient friendly subcutaneous administration per Li degree. In preclinical studies of a highly transformative Gubra Amylin NASH diet induced obesity (GAN-DIO) mouse model Whether used as monotherapy or in combination with approved or novel MASH therapies, the administration of TGM-312 significantly reduced non-alcoholic fatty liver disease activity score (NAS) and alleviated liver inflammation,
And slowed down the progression of fibrosis.
Jiachen Xihai mRNA vaccine has been approved for clinical trials by the US FDA for the treatment of acne
Recently, Jiachen Xihai, a biotechnology company specializing in mRNA technology platforms, announced today that its dual target therapeutic mRNA vaccine candidate JCXH-401 for the treatment of acne vulgaris has been approved for new drug clinical trials (IND) by the US Food and Drug Administration (FDA) and will soon begin phase one/two clinical trials.
The design of JCXH-401 aims to induce in vivo specific antibody responses that precisely target inflammatory mediators produced by pathogenic Propionibacterium acnes subtypes, without disrupting the normal microbial composition of the skin. This innovative mechanism is expected to minimize the risk of side effects such as antibiotic resistance, excessive skin dryness, and irritation, providing patients with a safer and more targeted treatment option.
Currently, only two mRNA candidate vaccines for acne vulgaris are under development worldwide, including JCXH-401 from Jiachen Xihai and another candidate vaccine from Sanofi. According to the plan, the first/second phase clinical trials of JCXH-401 will first focus on adult patients with moderate to severe acne.